Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

Cerebral Aneurysm Clinical Trial

Official title:

Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700607
• Other study ID #: KUH1160101
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2019
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing interventional cerebral aneurysm coiling procedure are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=10) and Group-HES (n=10).

All recruited patients will be given patient identification number (PIN) for the present study of 01-20 according to their order of interview and recruitment. Investigators will prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 20th patient's discharge and data acquisition

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing coiling embolization procedure due to cerebral aneurysm

• Patients provided a written informed consent.

• Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)

• Patients with PaO2/FiO2 ratio >150

Exclusion Criteria:

• Patients with history of anemia, dyspnea, active infection.

• Patients with endocrine disease

• Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• Intravenous Crystalloid
crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
• Intravenous HES
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole blood viscosity	whole blood viscosity measured by viscometer cm-1	with 1 hour after the completion of procedure
Secondary	PaO2/FiO2 ratio	PaO2/FiO2 ratio measured by arterial blood gas analysis	1 hour after the completion of procedure
Secondary	hematocrit	serum hematocrit, %	1 hour after the completion of procedure
Secondary	glucose	serum glucose level, g/dl	1 hour after the completion of procedure
Secondary	osmolarity	serum osmolarity, mosm	1 hour after the completion of procedure
Secondary	urine output	hourly urine output, ml/hr	1 hour after the completion of procedure